BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JIG, PARS

    MDR report key: 22298160 · Received June 20, 2025

    Report

    Report Number
    1220246-2025-02594
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 30, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867048621
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. ONE UNPACKAGED AR-8860J JIG, BATCH NUMBER 012432 WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION NOTED WEAR AND TEAR ALONG THE BODY: DISCOLORATION, FADING, AND CHIPPING. ADDITIONALLY, THE THREADS HAD DAMAGE/NICKS, WHICH ARE ALL LIKELY RELATED TO THE COMPLAINT ALLEGATION. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR, WHICH RESULTS FROM EXCESSIVE STRESS ON A DEVICE THAT HAS NATURALLY DETERIORATED OVER TIME DUE TO NORMAL USAGE AND AGING. THE COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 05/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8860J JIG, PARS ALIGNMENT WAS OFF. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670921 JIG, PARS ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. JIG, PARS 012432 00888867048621

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown